Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
Background:
- Ghrelin is a hormone in the human body that is mostly produced by the stomach. It makes
people feel hungry, and also is connected with the desire to drink alcohol. Researchers want
to test ghrelin to see if it can be used to control alcohol cravings and use. They will
compare doses of ghrelin with a placebo in people who drink heavily.
Objectives:
- To study the effects of ghrelin on alcohol craving and use.
Eligibility:
- Individuals between 21 and 60 years of age who are heavy drinkers but are not seeking
treatment for alcohol use.
- Participants must on average have more than 20 drinks per week for men, and more than 15
drinks per week for women.
Design:
- Participants will have a screening visit, four 2-night study visits, and a follow-up
visit.
- Participants will be screened with a physical exam and medical history. They will
provide urine and breath samples for drug testing. They will also answer questions about
mood and physical symptoms, and about alcohol and other cravings.
- At the study visits, participants will stay overnight at the National Institutes of
Health clinical center. They will spend the night at the center, have tests on the next
day, and go home on the following morning. At each visit, participants will receive a
ghrelin or placebo infusion, and will complete a series of tasks.
- For the first and second study visits, participants will have tests of alcohol craving
and use. They will be able to receive alcohol infusions through a computer program that
tests response time and craving reactions. At the same time, they will have a ghrelin or
a placebo infusion. Blood alcohol levels, reaction time, and craving will be studied.
- For the third and fourth study visits, participants will have a magnetic resonance
imaging (MRI) study. They will have an initial MRI to provide a picture of the brain.
They will then have a functional MRI during which they will respond to a computer test.
The test will allow them to win points for snack food or alcohol. This test will look at
the brain s response time and craving reactions.
- There will be a follow-up visit 1 week after the fourth study visit. Some of the tests
from the screening visit will be repeated.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)